Skin Graft (Allograft)(Autograft) FailureNCT04185636
Presence of Fluorescence Signature to Predict Graft Failure Using MolecuLight i:X
An observational study of Skin Graft (Allograft)(Autograft) Failure, run by MolecuLight Inc. at 1 site in United Kingdom.
Trial summary
This study will investigate whether the presence of a bacterial fluorescent signature captured by the MolecuLight i:X can predict a skin graft failure. The MolecuLight i:X is a handheld medical device which enables real-time standard digital imaging and fluorescence imaging of wounds and surrounding healthy skin of… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Skin Graft (Allograft)(Autograft) Failure
- What is being tested?
- MolecuLight i:X imaging
- Type of treatment
- Medical device
- How many people
- 20 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 15 Jan 2021to 15 Jun 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients presenting at 1 clinical site in the United Kingdom with a wound with a previous infection requiring a skin graft.
Who may be able to join
- Subjects with a wound with previous infection, requiring a skin graft
- 18 years or older
Who cannot join
- Subject has been treated with an investigational drug within 1 month before enrollment
- Subject is unable or unwilling to provide consent
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Birmingham City University Hospitals
Birmingham, West Midlands, B18 7QH
About this study
Official title: Prospective, Double-blind Assessment of the Presence of Fluorescence Signature to Predict Graft Failure Using MolecuLight i:X Imaging Device
This study will investigate whether the presence of a bacterial fluorescent signature captured by the MolecuLight i:X can predict a skin graft failure. The MolecuLight i:X is a handheld medical device which enables real-time standard digital imaging and fluorescence imaging of wounds and surrounding healthy skin of patients. When wounds are illuminated in fluorescence mode, collagen and other related proteins in the connective tissue matrix may emit a characteristic green fluorescent signal, while some bacteria may emit a unique red fluorescence signal due to endogenous porphyrin production and others may emit a unique cyan fluorescence signal due to the production of pyoverdine.
This is a non-randomized evaluation for which 20 adult patients will be imaged at University Hospitals Birmingham who present with a wound which has been previously infected and which requires a skin graft. The i:X will be used to take standard and fluorescent (FL) images of each graft site by the study team. The wound will be measured using the measurement application of the i:X, using WoundStickers. The clinician will be blinded to the results of these FL images until the end of the study. In this trial, the device is not intended to guide treatment. The images will be used after a 1-month patient follow up to correlate presence of bacterial fluorescence signature to graft failure. The hypothesis is that the presence of a bacterial fluorescence signature increases the likelihood of graft failure. The ability to predict graft failure would provide clinicians with more information on which to base a patient's suitability for a graft (e.g. determining if there is a heavy bacterial load present). This may lead to selection of appropriate therapies before a graft is applied.
Read the detailed description
This is a non-randomized evaluation for which 20 adult patients will be imaged at University Hospitals Birmingham who present with a wound which has been previously infected and which requires a skin graft. The MolecuLight i:X Imaging Device will be used to take standard (ST) and fluorescent (FL) images of each graft site. The MolecuLight i:X will also be used to take measurements of the wound using the measurement feature of the device.
Once a patient has identified as being suitable for the trial, the study will be introduced to them by a member of their circle of care. They will be provided with an informed consent form, provided time to consider the study and have any of their questions answered. The patient will be asked to sign and date the ICF if they choose to participate in the study.The subjects will be recruited for a period of 2 months.
The execution of the full protocol is expected to take approximately 15 minutes during a single clinic visit for each study subject. During the clinic visit, the clinician will treat the patient based on their clinical practice. Prior to the application of the skin graft, the Moleculight i:X will be used to take standard and fluorescent (FL) images of each graft site by the study team. The wound will be measured using the measurement application of the i:X, using WoundStickers. Following imaging the skin graft will be applied and treatment will continue as per the clinician's clinical practice.
The clinician will be blinded to the results of these FL images until the end of the study. In this trial, the device is not intended to guide treatment. There will be a follow-up with each patient at 1 month after the grafting procedure to ask if the grafting procedure was successful. There will not be any imaging or sampling required at the time of follow-up. The information gathered will be used for post-hoc analysis to assess if the presence of a fluorescence signal at the time of imaging is correlated to graft failure.
- Being tested
- MolecuLight i:X imaging
- Keywords
- Bacterial fluorescence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MolecuLight i:X imagingDevice
The MolecuLight i:X Imaging Device will be used to take standard (ST) and fluorescent (FL) images of each graft site. The MolecuLight i:X will also be used to take measurements of the wound using the measurement feature of the device.
| Study group | Role | What they receive |
|---|---|---|
| Skin Graft Patients | There will only be 1 group, patients receiving a skin graft and MolecuLight i:X imaging Receives: Device: MolecuLight i:X imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Graft success or failure
Correlation between presence of bacterial fluorescence signature in a wound and failure of a graft.
Measured: 1 month
Secondary outcomes (1)
Economic Analysis
Estimate the cost benefit of identifying and resolving an infection prior to graft (a. Estimate cost of graft procedure without complications, b. Estimate health care and quality of life cost of graft that becomes infected (initial graft, resolution of infection, secondary graft procedures, etc.), c. Estimate health care and quality of life cost of identifying infection prior to initial graft, resolve infection, and then graft procedure)
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2019
- Study start15 Jan 2021 (estimated)
- Primary completion15 Jun 2022 (estimated)
- Study completion15 Jun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin Graft (Allograft)(Autograft) FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- MolecuLight Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Steven Jeffery, MB ChB, Principal investigator, Birmingham City University Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04185636
- Sponsor's protocol ID
- 18-003
- Status last verified
- Mar 2020
- First submitted
- 29 Nov 2019
- Last updated
- 6 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: This study will not make IPD available to other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Double-blind Assessment of the Presence of Fluorescence Signature to Predict Graft Failure Using MolecuLight i:X Imaging Device
- ClinicalTrials.gov ID
- NCT04185636
- Acronym / sponsor ID
- 18-003
- Keywords
- Bacterial fluorescence
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- MolecuLight Inc.Industry (pharma, biotech, devices)
- Study start
- 15 Jan 2021 (estimated)
- Primary completion
- 15 Jun 2022 (estimated)
- Study completion
- 15 Jun 2022 (estimated)
- First posted
- 4 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will investigate whether the presence of a bacterial fluorescent signature captured by the MolecuLight i:X can predict a skin graft failure. The MolecuLight i:X is a handheld medical device which enables real-time standard digital imaging and fluorescence imaging of wounds and surrounding healthy skin of patients. When wounds are illuminated in fluorescence mode, collagen and other related proteins in the connective tissue matrix may emit a characteristic green fluorescent signal, while some bacteria may emit a unique red fluorescence signal due to endogenous porphyrin production and others may emit a unique cyan fluorescence signal due to the production of pyoverdine.
This is a non-randomized evaluation for which 20 adult patients will be imaged at University Hospitals Birmingham who present with a wound which has been previously infected and which requires a skin graft. The i:X will be used to take standard and fluorescent (FL) images of each graft site by the study team. The wound will be measured using the measurement application of the i:X, using WoundStickers. The clinician will be blinded to the results of these FL images until the end of the study. In this trial, the device is not intended to guide treatment. The images will be used after a 1-month patient follow up to correlate presence of bacterial fluorescence signature to graft failure. The hypothesis is that the presence of a bacterial fluorescence signature increases the likelihood of graft failure. The ability to predict graft failure would provide clinicians with more information on which to base a patient's suitability for a graft (e.g. determining if there is a heavy bacterial load present). This may lead to selection of appropriate therapies before a graft is applied.
Detailed description
This is a non-randomized evaluation for which 20 adult patients will be imaged at University Hospitals Birmingham who present with a wound which has been previously infected and which requires a skin graft. The MolecuLight i:X Imaging Device will be used to take standard (ST) and fluorescent (FL) images of each graft site. The MolecuLight i:X will also be used to take measurements of the wound using the measurement feature of the device.
Once a patient has identified as being suitable for the trial, the study will be introduced to them by a member of their circle of care. They will be provided with an informed consent form, provided time to consider the study and have any of their questions answered. The patient will be asked to sign and date the ICF if they choose to participate in the study.The subjects will be recruited for a period of 2 months.
The execution of the full protocol is expected to take approximately 15 minutes during a single clinic visit for each study subject. During the clinic visit, the clinician will treat the patient based on their clinical practice. Prior to the application of the skin graft, the Moleculight i:X will be used to take standard and fluorescent (FL) images of each graft site by the study team. The wound will be measured using the measurement application of the i:X, using WoundStickers. Following imaging the skin graft will be applied and treatment will continue as per the clinician's clinical practice.
The clinician will be blinded to the results of these FL images until the end of the study. In this trial, the device is not intended to guide treatment. There will be a follow-up with each patient at 1 month after the grafting procedure to ask if the grafting procedure was successful. There will not be any imaging or sampling required at the time of follow-up. The information gathered will be used for post-hoc analysis to assess if the presence of a fluorescence signal at the time of imaging is correlated to graft failure.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Skin Graft Patients | – | Device: MolecuLight i:X imagingThere will only be 1 group, patients receiving a skin graft and MolecuLight i:X imaging |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients presenting at 1 clinical site in the United Kingdom with a wound with a previous infection requiring a skin graft.
Key inclusion criteria (2 listed)
- Subjects with a wound with previous infection, requiring a skin graft
- 18 years or older
Key exclusion criteria (2 listed)
- Subject has been treated with an investigational drug within 1 month before enrollment
- Subject is unable or unwilling to provide consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MolecuLight i:X imagingThe MolecuLight i:X Imaging Device will be used to take standard (ST) and fluorescent (FL) images of each graft site. The MolecuLight i:X will also be used to take measurements of the wound using the measurement feature of the device. | Device | Skin Graft Patients |
Primary outcome
Graft success or failure
Time frame: 1 month
Correlation between presence of bacterial fluorescence signature in a wound and failure of a graft.
1 secondary outcome
Economic Analysis
Time frame: 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2020.
- Individual participant dataSharing planned: No. This study will not make IPD available to other researchers.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Steven Jeffery, MB ChB principal investigator
Birmingham City University Hospitals
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Skin Graft (Allograft)(Autograft) Failure, run by MolecuLight Inc. at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Graft success or failure (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2020.